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Scientific and Regulatory Policy Committee Points to Consider: Review of the United States Food and Drug Administration (FDA) Guidance on Pathology Peer Review in Nonclinical Toxicology Studies.
McDorman KS, Bennet BM, Colman K, Fikes JD, Keirstead ND, Lanning Retired L, Munch B, Romeike A, Schafer KA, Schorsch F, Thibodeau MS, Thomas HC, Troth S, Vahle JL, Geoly FJ. McDorman KS, et al. Among authors: fikes jd. Toxicol Pathol. 2024 Feb;52(2-3):138-148. doi: 10.1177/01926233241248654. Epub 2024 Jun 6. Toxicol Pathol. 2024. PMID: 38840532 Review.
Adeno-Associated Virus-Mediated Dorsal Root Ganglion Toxicity in the New Zealand White Rabbit.
Tien E, Grubor B, Kirkland M, Chan SJ, van der Munnik N, Xu W, Henry K, Hamann S, Wei C, Lee WH, Gianni D, Brennecke A, Nambiar K, Chen J, Liu B, Shen S, Tremblay C, Plowey ED, Trapa P, Fikes J, Suh J, Morris D. Tien E, et al. Among authors: fikes j. Toxicol Pathol. 2024 Jan;52(1):35-54. doi: 10.1177/01926233241229808. Epub 2024 Feb 22. Toxicol Pathol. 2024. PMID: 38385340
Scientific and Regulatory Policy Committee Points to Consider: Primary Digital Histopathology Evaluation and Peer Review for Good Laboratory Practice (GLP) Nonclinical Toxicology Studies.
Forest T, Aeffner F, Bangari DS, Bawa B, Carter J, Fikes J, High W, Hayashi SM, Jacobsen M, McKinney L, Rudmann D, Steinbach T, Schumacher V, Turner O, Ward JM, Willson CJ. Forest T, et al. Among authors: fikes j. Toxicol Pathol. 2022 Jun;50(4):531-543. doi: 10.1177/01926233221099273. Epub 2022 Jun 3. Toxicol Pathol. 2022. PMID: 35657014
Scientific and Regulatory Policy Committee Brief Communication: 2019 Survey on Use of Digital Histopathology Systems in Nonclinical Toxicology Studies.
Forest T, Aeffner F, Bangari DS, Bawa B, Carter J, Fikes J, High WB, Hayashi SM, Jacobsen M, McKinney L, Rudmann D, Steinbach T, Schumacher V, Turner OC, Ward JM, Willson CJ. Forest T, et al. Among authors: fikes j. Toxicol Pathol. 2022 Apr;50(3):397-401. doi: 10.1177/01926233221084621. Epub 2022 Mar 23. Toxicol Pathol. 2022. PMID: 35321602
Current strategies in the non-clinical safety assessment of biologics: New targets, new molecules, new challenges.
Brennan FR, Andrews L, Arulanandam AR, Blumel J, Fikes J, Grimaldi C, Lansita J, Loberg LI, MacLachlan T, Milton M, Parker S, Tibbitts J, Wolf J, Allamneni KP. Brennan FR, et al. Among authors: fikes j. Regul Toxicol Pharmacol. 2018 Oct;98:98-107. doi: 10.1016/j.yrtph.2018.07.009. Epub 2018 Jul 17. Regul Toxicol Pharmacol. 2018. PMID: 30026135
Use of Severity Grades to Characterize Histopathologic Changes.
Schafer KA, Eighmy J, Fikes JD, Halpern WG, Hukkanen RR, Long GG, Meseck EK, Patrick DJ, Thibodeau MS, Wood CE, Francke S. Schafer KA, et al. Among authors: fikes jd. Toxicol Pathol. 2018 Apr;46(3):256-265. doi: 10.1177/0192623318761348. Epub 2018 Mar 12. Toxicol Pathol. 2018. PMID: 29529947
A Diagnostic Approach for Rodent Progressive Cardiomyopathy and Like Lesions in Toxicology Studies up to 28 Days in the Sprague Dawley Rat (Part 2 of 2).
Hailey JR, Maleeff BE, Thomas HC, Pearse G, Klapwijk JC, Cristofori PG, Berridge B, Kimbrough CL, Parker GA, Morton D, Elmore S, Hardisty JF, Dybdal NO, Rehagen DA, Fikes JD, Lamb M, Biddle K, Buetow BS, Carreira V, Nyska A, Tripathi NK, Workman HC, Bienvenu JG, Brees I, Turk JR, Adler RR. Hailey JR, et al. Among authors: fikes jd. Toxicol Pathol. 2017 Dec;45(8):1055-1066. doi: 10.1177/0192623317743948. Toxicol Pathol. 2017. PMID: 29233079
A Diagnostic Approach for Rodent Progressive Cardiomyopathy and Like Lesions in Toxicology Studies up to 28 Days in the Sprague Dawley Rat (Part 1 of 2).
Hailey JR, Maleeff BE, Thomas HC, Pearse G, Klapwijk JC, Cristofori PG, Berridge B, Kimbrough CL, Parker GA, Morton D, Elmore S, Hardisty JF, Dybdal NO, Rehagen DA, Fikes JD, Lamb M, Biddle K, Buetow BS, Carreira V, Nyska A, Tripathi NK, Workman HC, Bienvenu JG, Brees I, Turk JR, Adler RR. Hailey JR, et al. Among authors: fikes jd. Toxicol Pathol. 2017 Dec;45(8):1043-1054. doi: 10.1177/0192623317743938. Epub 2017 Nov 26. Toxicol Pathol. 2017. PMID: 29173114
81 results